Application 202882

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASENoNo
002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 40MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202882-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10
A202882-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202882-001AB
A202882-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1084e616aacf4f…
2026-09-14 22:38:342026-08A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1084e616aacf4f…
2026-08-18 06:07:402026-07A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202882-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202882-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2014-09-1074a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202882-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202882-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A202882-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202882-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202882-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202882-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202882-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202882-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202882-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202882-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202882-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202882-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202882-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202882-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202882-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202882-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202882-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202882-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202882-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202882-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202882-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202882-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202882-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202882-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202882-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202882-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202882-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202882-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202882-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202882-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202882-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202882-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202882-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202882-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202882-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202882-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202882-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202882-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202882-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202882-002AB174a2ff9319b5…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANTOPRAZOLE SODIUMPANTOPRAZOLEAvPAK59f50bcb-85e5-e3f6-e063-6294a90a11ae2026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEPreferred Pharmaceuticals Inc.5c14e2f3-625d-4089-a404-440b0ecf72e72026-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLESportpharm LLCb58c376e-616b-4970-a375-52ff630e7f092026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEHAWAII REPACK, INC.f85e6d64-1ddc-4f4a-86dc-0749081a6a5f2026-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLESt. Mary's Medical Park Pharmacye1aa55ec-5e0e-3a58-e053-2a95a90abe4f2026-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch Prepackfa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
Pantoprazole Sodium DRPANTOPRAZOLE SODIUM DRDirect_Rx0515ceaa-7d17-c92f-e063-6294a90a044e2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEPD-Rx Pharmaceuticals, Inc.c1f37929-a981-4ace-95e6-ae6795a797b32026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.9daa1483-5a36-44db-9e0d-904d100da2622026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEQuallent Pharmaceuticals Health LLC643eb498-d916-4fb7-9281-32895575ab362026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
ndc (product): 82009-011
ndc (product): 82009-010
PANTOPRAZOLE SODIUMPANTOPRAZOLENorthwind Health Company, LLCda67e1c0-9947-957d-e053-2a95a90ad96d2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEQPharma Incb4a94a37-47c1-4dd9-9e4d-5b4a03480aa62025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEDIRECT RXa7e7c1ab-3e75-1ff8-e053-2995a90a75392025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCc89a5396-1d94-c7fa-e053-2995a90a90632024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
ndc (product): 80425-0162
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCbd4759ac-46b5-6903-e053-2a95a90a63192024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf5c9e3c6-d4b0-0ebe-e053-2995a90abe552024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.a9f32edf-e0b9-4e96-e053-2a95a90afbc82024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.b2abc159-e450-99dc-e053-2a95a90abe6a2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LP50a278de-bd16-417c-a741-81bfe0d745f22024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.8748a588-a1e5-9dfc-e053-2a95a90a846c2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202882
application number: ANDA202882

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 88 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
80425-0162Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0162Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0162Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0162Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
82009-010PANTOPRAZOLE SODIUMPANTOPRAZOLEQuallent Pharmaceuticals Health LLCANDACurrent
82009-010PANTOPRAZOLE SODIUMPANTOPRAZOLEQuallent Pharmaceuticals Health LLCANDACurrent
82009-011PANTOPRAZOLE SODIUMPANTOPRAZOLEQuallent Pharmaceuticals Health LLCANDACurrent
82009-011PANTOPRAZOLE SODIUMPANTOPRAZOLEQuallent Pharmaceuticals Health LLCANDACurrent